Filing Requirements and Deadlines

Please note this page is being updated to reflect the new PMPRB Guidelines

Patentee and Medicine Information
Information Timing Patent Act Regulations Form
Identity of medicine, patentee and patent(s)

Earliest of:

Seven (7) days after the date the first Notice of Compliance issued

Seven (7) days after the date the medicine is first offered for sale in Canada

80(1)(a)
80(2)(a)		 3(1) 3(2)
3(3)		 1
Updating information on identity of medicine/patentee Within thirty (30) days after any modification of information 3(4) 1
Price and Sales Data
Information Timing Patent Act Regulations Form

Price and sales data for the medicine sold to province/territory in Canada

Publicly available ex-factory price sold in Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden and United Kingdom

When a drug is first offered for sale in Canada, no later than thirty (30) days after the first day of sales

On or before July 30 (January 1 to June 30 reporting period)

On or before January 30 (July 1 to December 31 reporting period)

80(1)(b) 80(2)(b)

4(1)

4(2)

 2
Revenue and R&D Expenditures
Information Timing Patent Act Regulations Form
Revenues from sales and expenditures on R&D On or before March 1 of each year 88(1) 88(2) 5, 6 3
National Market Size Estimation of Medicine
Information Timing Patent Act Regulations Form

National market size estimation of medicine

Within 30 days after the day on which the medicine is first offered for sale in Canada

In the case of a medicine that is offered for sale in Canada before July 1, 2021, the most recent version of the estimated maximum use of the medicine shall be provided

(a) if the medicine is first offered for sale in Canada during the period beginning on January 1, 2018 and ending on June 30, 2021, by July 30, 2021; or

(b) if the medicine is first offered for sale in Canada before January 1, 2018, but the Minister of Health assigns a drug identification number under the Food and Drug Regulations

(i) during the period beginning on August 21, 2019 and ending on June 30, 2021, by July 30, 2021, or

(ii) after June 3, 2021, within 30 days after the day on which the drug identification number is assigned

 80(1)(d)
80(2)(d)		 4.2 4
Cost Utility Analysis (CUA)
Information Timing Patent Act Regulations Form

Cost-utility analysis prepared by a publicly funded Canadian organization

(a) if the analysis is published before the day on which the medicine is first offered for sale in Canada, within 30 days after that day; or

(b) if the analysis is not published before the day on which the medicine is first offered for sale in Canada, within 30 days after the day on which it is published.

In the case of a medicine that is offered for sale in Canada before July 1, 2021, an analysis shall be provided

(a) if the analysis is published before July 1, 2021, by July 30, 2021; or

(b) if the analysis is not published before July 1, 2021, within 30 days after the day on which it is published.

 80(1)(d)
80(2)(d)		 4.1 -
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